Phase 2 N=49 Randomized Double-blind Basic Science

Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana

Marijuana Use

Bottom Line

View on ClinicalTrials.gov: NCT00403117 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. — 8.0; 25.0; 6.7; 34.0 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo + Inactive Marijuana (0% THC) (Drug); Placebo + Active Marijuana (3.27% THC) (Drug); Naltrexone 12 Mg+ Active Marijuana (3.27% THC) (Drug); Naltrexone 25 Mg + Active Marijuana (3.27% THC) (Drug); Naltrexone 50 Mg+ Active Marijuana (3.27% THC) (Drug); Naltrexone 100 Mg+ Active Marijuana (3.27% THC) (Drug); Naltrexone 12 Mg + Inactive Marijuana (0% THC) (Drug); Naltrexone 25 Mg + Inactive Marijuana (0% THC) (Drug); Naltrexone 50 Mg + Inactive Marijuana (0% THC) (Drug); Naltrexone 100 Mg + Inactive Marijuana (0% THC) (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.	8.0; 25.0; 6.7; 34.0; 8.1; 31.6	—
PRIMARY Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose	86.2; 86.1; 86.7; 84.7; 83.4; 83.5	—
PRIMARY Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.	68.5; 70.7; 65.8; 72.1; 67.3; 72.7	—

Summary

The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses ( 50 mg) of naltrexone.

Eligibility Criteria

Inclusion Criteria

Current marijuana use
Able to perform study procedures
21-45 years of age
Women practicing an effective form of birth control

Exclusion Criteria

Current, repeated illicit drug use (other than marijuana)
Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory hepatitis, clinically significant laboratory abnormalities, tests, 12-lead ECG, Mantoux test LFTs > 3x upper limit of normal)
History of heart disease
Request for drug treatment
Current parole or probation
Pregnancy or current lactation
Recent history of significant violent behavior
Previous adverse reaction to naltrexone
Major current Axis I psychopathology Psychiatric interview (e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
Current use of any prescription or over-the-counter medication

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00403117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.